Since the introduction of antiretroviral therapy life expectancy of HIV-infected persons is rising. Different cohorts are observing an increased risk for cardiovascular diseases in this aging HIV-infected population. Traditional cardiovascular risk factors like smoking are more frequent in HIV-infected persons. For example chronic inflammation due to HIV-infection and metabolic disorders also caused by some antiretroviral substances as special non-traditional risk factors in HIV-infected persons can influence the development of cardiovascular diseases additionally. Therefore new research focus in special risk profile associated with HIV-infection or antiretroviral treatment and prevention for HIV-infected patients is developing.

This present study is an ongoing prospective regional multicenter trial that was conducted to analyse the incidence, prevalence and clinical course of cardiovacular disorders in HIV-infected out-patients.

Cardiac disorders witch are associated with HIV are pericarditis, pleural effusion, pulmonary hypertension, dilated cardiomyopathy, heart failure, myocarditis, bacterial endocarditis and heart valve disorders. In addition to previously stated disorders of the heart, the premature atherosclerosis of coronary arteries, a further even more important disease of the heart in this patient population, went into the focus of most HIV-researchers and physicians.

Cardiovascular Diseases in HIV-infected Patients [ Time Frame: Baseline up to 7.5 follow-up to ] [ Designated as safety issue: No ]

The detection of prevalence, aetiology, progression and severity of cardiovascular diseases - especially of coronary artery disease in HIV-infected patients.

Secondary Outcome Measures:

Cardiovascular Disorders in HIV-infected Patients HIV-HEART [ Time Frame: Baseline up to 5 years follow-up ] [ Designated as safety issue: No ]

Complementary the study also investigates the impact of classic cardiovascular risk factors like gender, age, blood fat and also new HIV-specific risk factors of coronary artery disease like viral-load, CD4-cell count and stage of the infection. The HIV-HEART study will focus the impact of medication including cardiovascular and antiretroviral medication. Further secondary objectives will be examined, including economic costs and the subjectively quality of life of subjects with and without cardiovascular diseases in this patient population.

HIV-positive patients in the German Ruhr-Region from out-patient clinics of hospitals and HIV-physicians pratices

Other: Comprehensive non invasive cardiovascular examination

Anamnesis with the participian

File recherche,Physical examination

Documentation of the carciovascular and antiretroviral medical therapy

Electrocardiogram

Transthoracic echocardiography

Exercise electrocardiogram

Measuring of the arterial media thickness

Exercise Montreal Cognitive Assesment test

Exercise the Grooved Pegboard test

Blood collection

Questionnaire to quality of life and health economics

Detailed Description:

A comprehensive detailed description of the study procedures had been previously published (European Journal of medical research 2007;12:243-248).

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Participiants were included in several cities of the Ruhrarea. Locations were Essen, Bochum, Dortmund and Duisburg The study population included outpatients who were at least 18 years of age, had a known HIV-infection and exhibited a stable disease status within 4 weeks before inclusion of the trial. Written informed consent was obtained from all participants.

Criteria

Inclusion Criteria:

Age > 18 years

Known HIV-infection

Written informed consent

Exclusion Criteria:

Acute cardiovascular disease

Unstable hemodynamic status in the three weeks before inclusion

Pregnancy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667068